The Assisted Reproductive Technology (Regulation) Act, 2021: Features, Challenges and Way Forward

Context: The Ministry of Health and Family Welfare has asked all States and UT’s for data on the total count of single women (divorcees/widows) and unmarried women who have effectively utilized Assisted Reproductive Technology (ART). The aim is to evaluate the implementation of the ART Act, 2021.

Highlights of the Assisted Reproductive Technology (Regulations) Amendment Rules, 2023

• Fertility experts have welcomed the move for inclusion of single women/unmarried women as a category.
• The Ministry has also notified the Assisted Reproductive Technology (Regulations) Amendment Rules, 2023, under the Assisted Reproductive Technology (Regulation) Act, 2021 to provide donors and patients with better care. 
• The Health Ministry had also sought category-wise data of the total number of couples and single women who used surrogacy successfully following the implementation of the Surrogacy Act, 2021.
• The request to share the data of successful ART cases will give information related to the success rate of various ART clinics. 

What are Assisted Reproductive Technology (ART) Services?

• ART includes techniques for obtaining a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.  
• These include gamete donation (of sperm or egg), in vitro fertilization, and gestational surrogacy.  

About Assisted Reproductive Technology (Regulation) Act 2021 Or ART Act 2021

• About: Assisted Reproductive Technology (Regulation) Act was passed on December 20, 2021 to regulate the practice of ART clinics and ART banks in India.
• Objective: It deals with proper supervision, regulation, licensing, and ensuring good ethical practices in the rapidly evolving field of assisted reproduction.
• Significance: With the advent of in vitro fertilisation (IVF) technology, there has been a rise in ART clinics in the country necessitating the need for supervision and regulation to safeguard the rights of women seeking fertility treatment. 

Features of ART Act 2021

• Provision of ART services: ART services will be provided through ART clinics, which offer ART related treatments and procedures, and  ART banks, which collect, screen and store gametes.   
• Registration of ART clinics and banks: Under the act, a National Registry is to be maintained which acts as a central database with details of all ART clinics and banks in the country.  
  • The central and state governments have to appoint appropriate authorities to support registration related services.
• National and State Boards:  The National and State Boards constituted under the Surrogacy Act 2021 will also act as the National and State Boards for the regulation of ART services.  
• Registration of Clinics: The central government will appoint authorities called the Appropriate Assisted Reproductive Technology and Surrogacy Authority which will regulate the registration of clinics for both surrogacy and ART services. 
  • The Authorities will be constituted at national and state level.
• Eligibility Criteria for Commissioning Parties:  ART services may be commissioned by Single women or married couples where the woman is between 21 and 50 years of age, and the man is between 21 and 55 years and the married couples must be infertile.
  • Foreigners are not prohibited from availing ART services. 
• Eligibility Criteria for Donors:  A bank may obtain semen from males between 21 and 55 years of age, and eggs from females between 23 and 35 years of age.  
  • The woman may donate eggs only once in her life and not more than seven eggs may be retrieved from her.  
  • A bank must not supply gametes of a single donor to more than one commissioning party (i.e. couples or single women seeking services).
• Conditions for Offering Services: ART procedures must be conducted only with the written consent of the commissioning parties and the donor.  
  • Genetic disease screening:Clinics are required to check for genetic diseases before implantation and are prohibited from providing any sex-selective services (e.g. sex determination).
  • Insurance Coverage for donor: Parties seeking ART services have to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor). 
• Rights of a child born through ART:  A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple.  
  • A donor will not have any parental rights over the child.
• Duties of ART Clinics and Banks:  ART clinics and banks have to share information related to enrolment of the commissioning parties and donors, procedures being undertaken, and outcome of the procedure, with the National Registry.  
  • The records of all donations have to be maintained for at least 10 years, after which the records must be transferred to the National Registry.   
• Regulating Surrogacy: The Act brings into its ambit the treatment of surrogacy and hence ensures protection of the rights of surrogate mothers. 

Challenges With ART Act 2021

• Concerns of Privacy Violation: The requirement of ART clinics and banks to share personal information of the donors and the commissioning parties with the National Registry risk the violation of their privacy rights.
• No provisions for Counselling for Donors: While the ART Act mandates ART clinics to offer counseling services to commissioning parties regarding the success probabilities of ART procedures, there is absence of provisions related to counseling for donors.
• Lack of consent for donors: Commissioning parties may withdraw consent before the embryo or gamete is transferred to the woman’s uterus. However,  donors have not been given similar rights to withdraw their consent. 
• Issue of Qualification of Professionals not Addressed: The Act does not address the issue of qualification, experience, and the desired skills of the professionals working in ART clinics and banks.
• No regulation of adoption:  Adoption is generally pursued by couples after unsuccessful fertility treatment. However, adoption remains unregulated in India.
• Challenges in Implementation: The registration process for the numerous ART clinics and ART banks operating in the country is challenging.
  • Ensuring compliance with all aspects of the Act, particularly the strict enforcement of fines and other penalties for non-compliance, is a formidable task for both national and state ART and surrogacy boards. 
  • Since health is a state subject, each state has to formulate context-specific rules suitable for their settings. 
• Difficulty in Finding Suitable Donors: The restrictions significantly limit the opportunities for ART couples to find suitable donors. 
  • India, much like the rest of the world, is facing a decrease in fertility rates and further limiting available donors has led to increased problems for commissioning parties.
• Concerns with International Surrogacy Contracts: Legal complications from the signing of surrogacy contracts between international couples and local women offering surrogacy services. 

Surrogacy Act 2021 Vs ART Act 2021

Must Read: Rights Of Women Vs. Rights Of The Unborn Child

Way Forward

• Protecting Privacy Rights:  As recommended by the Standing Committee, the personal data of patients and commissioning couples should be converted to a form  so as to maintain their confidentiality.
  • The data should be collected for a specific purpose and kept for the period required for that purpose. 
• Addressing International Surrogacy Contracts: There should have been a detailed provision addressing any disputes arising from surrogacy contracts. 
  • This becomes significant considering the involvement of many international couples from developed countries seeking surrogacy services in a developing country like India.
• Provision for Regulating Adoption: Regulation of adoption should need to be addressed alongside ART and surrogacy.

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